None listed
Conditions
Interventions
Sponsors
The Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Fully understand and voluntarily participate in this research and sign the informed consent; 2. Subjects who elect to undergo total hysterectomy under general anesthesia (no limit to the size of the surgical incision), or other abdominal surgery (except total hysterectomy) expecting a single incision >=3cm, the expected operation time is about 1-3 hours; 3. Subjects with American Society of Anesthesiologists (ASA) grades I-II (for specific scoring standards, see Appendix 3 American Society of Anesthesiologists (ASA) scoring standards); 4. Aged 18-65 years, no gender restrictions; 5. 18 kg/m^2 = 48 hours of PCIA treatment after surgery; 7. Be able to understand the research process and the use of pain scales, be able to operate PCIA (patient-controlled analgesia) equipment, and be able to communicate effectively with researchers.
Exclusion criteria
Exclusion criteria: 1. Received open or laparoscopic surgery within 1 year before randomization; 2. Those with active bleeding diseases such as peptic ulcer and perforation within 6 months before randomization may be aggravated by taking NSAIDs, and they are not suitable to participate in the trial after evaluation by the investigator; 3. Subjects with a history of myocardial infarction or coronary artery bypass grafting within 1 year before randomization; 4. Complicated with severe liver, kidney, cardiovascular and cerebrovascular diseases, and metabolic system diseases, the investigators have determined that they are not suitable to participate in this trial; 5. Subjects with neurological diseases such as migraine and epilepsy, which are judged by the investigator to affect the evaluation of the efficacy of the experimental drug; 6. Combined with chronic pain, other physical pain conditions that may confuse postoperative pain evaluation as determined by the investigator; 7. Subjects with advanced malignant tumor or malignant tumor with extensive metastasis; 8. Hypertensive subjects who have not received regular antihypertensive treatment or whose blood pressure is poorly controlled: (1) Sitting systolic blood pressure >= 160mmHg and/or diastolic blood pressure >=100mmHg during screening); (2) Sitting systolic blood pressure 450ms, female>470ms (QTc is calculated by Fridericia formula); 10. Those with poor blood sugar control before screening, random blood sugar >=11.1mmol/L; 11. Abnormal liver function during the screening period: aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >= 1.5xULN and/or total bilirubin (TBIL) >= 1.5xULN; 12. Abnormal renal function during the screening period: serum creatinine (Cr)>=1.5 xULN; 13. Abnormal coagulation function during the screening period: Prothrombin time (PT) is prolonged beyond the upper limit of normal for 3 seconds and/or activated partial thromboplastin time (APTT) is prolonged beyond the upper limit of normal for 10 seconds; 14. Abnormal platelet count during screening: platelet count <50x10^9/L; 15. Hemoglobin <90 g/L; 16. Infectious disease screening, positive for syphilis antibody and human immunodeficiency virus (HIV) antibody test; 17. Known allergies or contraindications to meloxicam and excipients, aspirin and other NSAIDs, and other drugs that may be used during the trial; 18. Received the following drug treatments before randomization: cancer subjects treated with radiotherapy, chemotherapy or other biological therapy (within 60 days before the screening period), long-acting NSAIDs such as meloxicam tablets (within 7 days before randomization), other NSAIDs (3 days before randomization); 19. For other drugs used before randomization and judged by the researchers to affect the analgesic effect, the last use time is less than 5 half-lives from randomization (subject to the actual drug instructions), including but not limited to monoamine oxidase inhibitors, glucocorticoids (intravenous), sedatives (except propofol for intraoperative sedation), antiepileptic drugs, antidepressants, anticonvulsants, anti-anxiety drugs, etc. (refer to Table 6 for specific types); 20. Subjects who may affect the effectiveness and safety evaluation of the test drug due to alcohol, drug and drug withdrawal during the research period; 21. Female subjects who are pregnant or breastfeeding; subjects with childbear
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Numerical Score Pain Intensity Score;Subject satisfaction score; | — |
Countries
China
Contacts
Public ContactOuyang Wen
Outcome results
None listed